Dental implant system and additional methods of attachment

ABSTRACT

A dental implant assembly with an an abutment head integrally joined to an implant body. The top section of the abutment head a shape formed by a linear wall adjacent to an arcuate wall; a ledge is located beneath the top section of the abutment; and the abutment head extends above the ledge a distance of from about 2 to about 4 millimeters. The implant body has a base section and a neck section, each of which has a different degree of roughness.

CROSS-REFERENCE TO RELATED PATENT APPLICATION

This application is a continuation-in-part of applicant's copendingpatent application U.S.S.N. 09/967,556, now abandoned, filed on Sep. 28,2001.

FIELD OF THE INVENTION

A dental implant device comprised of an irregularly-shaped abutment.

BACKGROUND OF THE INVENTION

Dental implants have been known and used since at least the 1930's; see,e.g., U.S. Pat. No. 5,312,254 of Joel L. Rosenlicht. See also U.S. Pat.No. 5,145,371 of Lars Jomeus which discusses the osseointegration methodof integrating a dental implant into a patient's jaw. The disclosure ofeach of these patents is hereby incorporated by reference into thisspecification.

A wide variety of dental implant styles and systems are currentlyavailable. For example, dental implants having cutting means are alsoknown in the art, as disclosed in U.S. Pat. No. 5,338,197, thedisclosure of which is hereby incorporated by reference into thisspecification. Another type of dental implant assembly is one that usesa hexagonal abutment implant system. This assembly is disclosed in U.S.Pat. No. 5,564,924, of which the disclosure is also herein incorporatedby reference.

Applicant has described several dental implant devices in U.S. Pat. Nos.5,574,924, 5,733,124, and 6,068,479; the entire disclosure of each ofthese United States patents is hereby incorporated by reference intothis specification. Furthermore, reference also may be had toapplicant's International Patent No. WO 02/26157 A1, the entiredisclosure of which is also hereby incorporated by reference into thisspecification.

It is an object of this invention to provide an improved dental implantdevice.

SUMMARY OF THE INVENTION

In accordance with this invention, there is provided a universal dentalimplant system containing a head portion and a base portion. The baseportion includes fastening elements to secure the implant within ajawbone of a patient. The head portion is comprised of a multiplicity oflinear walls, at least one of which is disposed angularly in a mannerdifferent than the other such walls.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by reference to the following drawings,in which like numerals refer to like elements, and in which:

FIG. 1A is a schematic view of one preferred apparatus of the invention;

FIGS. 1B is a top view of another embodiment of the invention;

FIG. 2 is a partial side view of one preferred one-piece universalimplant-abutment device;

FIG. 3 is a sectional view of the device of FIG. 1A;

FIG. 4 is a schematic view of a healing ball of a preferred dentalimplant system;

FIG. 5 is a schematic of another embodiment of a healing ball of thedental implant system;

FIG. 6A is a perspective view of one embodiment of a dental implantsystem of the present invention as inserted within the jawbone of apatient;

FIG. 6B is a perspective view of another embodiment of a dental implantsystem of the present invention as inserted within the jawbone of apatient;

FIG. 7 is a schematic view of an analog-abutment of a dental implantsystem;

FIG. 8 is a perspective view of a retaining screw of a dental implantsystem;

FIG. 9 is a perspective view of a guide pin of a dental implant system;

FIG. 10 is a schematic view of an incision formed as part of a processof attachment of the dental implant system in accordance with thepresent invention;

FIG. 11 is a schematic illustration of a tissue flap formed as part ofthe methods of attachment of a dental implant system;

FIG. 12 is a schematic illustration of a hole formed as part of themethods of attachment of the dental implant system in accordance withthe present invention;

FIG. 13 is a schematic illustration of a implant-abutment deviceinserted within the hole of FIG. 12;

FIG. 14 is a schematic illustration of a healing ball seated on thedevice of FIG. 13;

FIG. 15 is a schematic illustration of an impression tray;

FIG. 16 is a schematic illustration of an impression formed as part ofthe process of attachment of a dental implant system;

FIG. 17 is a schematic illustration of an analog-abutment insertedwithin the impression of FIG. 16;

FIG. 18 is a schematic illustration of a model formed as part of theprocess of attachment of the dental implant system;

FIG. 19 is a schematic illustration of one embodiment of a prosthesisformed as part of the process of attachment of the dental implantsystem;

FIG. 20 is a schematic illustration of multiple implant-abutment devicesinserted within the jawbone of a patient;

FIG. 21 is a schematic illustration of another embodiment of animpression tray;

FIG. 22 is a schematic illustration of one embodiment of an alignment ofmultiple implant abutment devices of a dental implant system;

FIG. 23 is a schematic illustration of another embodiment of multipleimplant-abutment devices modified as part of the methods of attachmentof the dental implant system;

FIG. 24 is a schematic illustration of yet another embodiment ofmultiple implant-abutment devices modified as part of the methods ofattachment of the dental implant system;

FIG. 25 is a schematic illustration of another embodiment of a modifiedimplant-abutment device;

FIG. 26 is a schematic illustration of a section of a template of thedental implant system;

FIG. 27 is a schematic illustration of one embodiment of a section of atemplate positioned on an implant-abutment device;

FIG. 28 is an exploded view of an embodiment of an abutment used in thedevice of this invention;

FIGS. 28A and 28B are perspective views of other abutment assemblies;

FIG. 29 is top view of the abutment of FIG. 28;

FIGS. 29A and 29B are top views of other abutment assemblies;

FIGS. 30A, 30B, 30C, 30D, 30E, 30F, 30G, 30H, 30I, 30J, and 30K are topviews of other preferred abutment assemblies;

FIGS. 31A and 31B are perspective and top views, respectively, ofanother implant assembly of the invention;

FIG. 32 is an exploded schematic view of a preferred implant assembly ofthe invention;

FIGS. 32A and 32B, are sectional views of preferred abutment assembliesof the invention; and

FIGS. 33A, 33B, 33C, 33D, 33E, 33F, 33G, and 33H are top views of otherpreferred abutment assemblies of the invention.

FIG. 34A is a perspective view of another implant assembly of theinvention;

FIG. 34B is a sectional view of another implant assembly of theinvention;

FIGS. 35, 36, 37A and 37B are perspective views of other implantassemblies of the invention; and

FIG. 38 is a sectional view of a roughened surface.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In general, dental implants are moderately expensive, ranging in costfrom approximately two to four hundred dollars (excluding laboratorycosts). However, the labor associated with the implant procedure oftencosts eight to twenty times the amount of the implant itself, rangingfrom about three to four thousand dollars per tooth. One of the reasonsfor this substantial cost is the multiplicity of steps required by theimplant procedure. An example of these prior art steps will be describedbelow with reference to Nobelpharma catalog PRI 385 94, 2nd edition(published by the Nobelpharma AB, Box 5190, S-402 26 Goteborg, Sweden).

In the first step of the prior art procedure, an implant or “fixture” ispurchased; see, e.g., page 7 of the Nobelpharma catalog and thereference to the 3.75 millimeter and 4.0 millimeter titanium fixturesillustrated on such page. The fixture so purchased must then be placedinto an “instrument set for fixture placement,” which is shown on page22 of the Nobelpharma catalog.

Once the fixture is disposed in the “instrument set . . . 2, “a “fixturemount” is then attached to the fixture by means of a wrench and ascrewdriver. The “fixture mount” devices are shown on page 22 of theNobelpharma catalog. The instruments for fixture placement of thefixture are also shown on page 22 of the Nobelpharma catalog (see wrenchpart 17 and screwdriver part 19).

Next, a “connection to contra-angle handpiece” (see part 11 on page 22of the Nobelpharma catalog) is attached to a handpiece (see page 31 ofthe Nobelpharma catalog) and the implant assembly is then driven intothe jawbone of a patient.

Thereafter, the fixture mount is removed from the fixture and a coverscrew 10 (see page 9 of the Nobelpharma catalog) is inserted into thefixture. Next, the surgical site is allowed to heal for about three toabout six months. See, e.g., Branemark/Zarb/Alberektsson: “TissueIntegrated Prostheses” (Quintessence Books, 1985).

After the healing period, the implant is exposed by surgical proceduresand the cover screw is removed. A healing abutment (see page 39 of theNobelpharma catalog) is then attached to the fixture. In general, thehealing abutment is left in place for approximately two to three weeks,depending upon how the patient's tissue has healed.

Thereafter, the healing abutment is removed and an implant abutment isattached to the fixture. The type of implant abutment used will dependon the requirements of the patient. Thus, for example, referring topages 38 and 39 of the Nobelpharma catalog, one may use a standardabutment, an “EsthetiConee” abutment, a “CeraOneo” abutment, a “BallAttachment,” an Angulated Abutment,” and other standard and/orproprietary abutments.

Next, the desired prosthesis is formulated by conventional means andadjusted to fit within the patient's mouth. For a single-toothprosthesis, generally one to two impressions are made to capture thesize and shape of the abutment to the tooth.

Multiple mock-ups and adjustments are often made before the finalprosthesis is finally secured to the implant.

For a multiple-tooth prosthesis, the course of treatment is not alwayspredictable; multiple impressions and frameworks need to be createdinvolving multiple appointments. Typically, the entire treatment,including initial implant placement and second stage surgery, would spana period of time ranging from two to approximately nine to eighteenmonths, or longer, before the final prosthesis is secured within thepatient's mouth.

In addition to the increased time, labor and costs, various theoreticaland practical implications need to be considered for multiple tooth orfull-mouth reconstruction. In multiple restorations, “draw,” “commonpath of insertion,” “parallel,” “passivity” and “stability’ are termsthat describe the most critical objectives of such a procedure.

Draw is perhaps best described as the effects of friction, but notbinding.

Multiple implants and their abutments are rarely, if ever, perfectlyaligned within the patient's mouth. Traditional methods of multipletooth restoration require the heads/abutments and prostheses to bemodified or made parallel until a common path of insertion is achievedand until the prosthesis is passive with respect to all of the abutmentsand soft tissue. In other words, it must be possible to place theprosthesis in position by moving the structure onto the abutments in astraight line (i.e., the common path of insertion), with sufficientfriction or draw to ensure a firm fit. Once in place, the prosthesismust be passive, which means it must fit the abutments and the softtissue profile such that there is no undue tension and no motion cantake place.

These prior art procedures require a myriad number of instruments andparts, typically two surgical procedures, many trips by the patient tothe dentist, increased treatment times and prolonged healing periodsresulting in an overall reduced quality of life for the patient.Further, an expensive, time consuming and labor intensive “trial anderror” system is crucial to such procedures because each prosthesis iscustom made to the particular shape, design, location and quantity ofabutments for each patient. Therefore, not only are the processestedious and expensive, but, also, each surgical procedure introduces acertain element of risk, pain, and suffering.

In view of the above, there is a need for a dental implant system andassociated process of attachment that are simple, predictable andeffective. In particular, it is desirable that the dental implant systemand attachment process include universal, interchangeable components,reduce post-operative infection, improve device/prosthesis strength andprolong its stability, and reduce the overall time for reconstructionprocedures. It is also desirable that the dental implant system andassociated process enable a practitioner to form a final prosthesis,including an infinite number of facsimiles of said final prosthesis,based on a single impression.

One embodiment of the present invention contemplates a method of dentalreconstruction comprising inserting one or more devices into anedentulous space within a patient's mouth, wherein each of the devicesincludes a head portion. The method further includes placing a healingball on each of the heads of the devices and forming a dental impressionwith impression material, wherein the healing balls transfer with theimpression material upon removal from a patient's mouth. In addition,the method includes mounting an analog-abutment within each of thehealing balls of the impression, forming a final model of the dentalimpression including the analog abutments, wherein the final modelreplicates the patient's edentulous space and creating a finalprosthesis using the final model. Lastly, the method includes installingthe final prosthesis within the edentulous space of the patient, Thepresent invention also contemplate a universal dental implant systemcomprising a head portion and a base portion, wherein the base portionincludes fastening elements to secure the implant within a jawbone of apatient. The system further includes a healing ball, wherein the healingball mounts onto the head portion.

In addition, the system further includes a retaining screw or guide pinthat secures the healing ball onto the head portion.

In addition, one embodiment of the present invention also contemplates amethod of forming a dental prosthetic comprising fixing a stud elementin a predetermined site, placing a removable protective element on thestud element and forming a first impression over the protective elementat the predetermined site. The method also includes removing theprotective element from the stud element with the first impression,mounting an abutment in the protective element contained in the firstimpression, forming a second impression over the abutment such that thesecond impression substantially replicates the predetermined site, andcreating a prosthesis by relying on information provided by the secondimpression.

Another embodiment of the present invention contemplates a method offorming a dental prosthetic comprising providing a first impressionwhich replicates a dental site, inserting a fixation element into thefirst impression, providing a second impression which replicates thedental site and retains the fixation element and modifying the fixationelement on the second impression as needed so as to provide sufficientinformation to create the prosthetic.

Yet another embodiment of the present invention contemplates a model forcreating a dental prosthetic comprising a form replicating the region ofan edentulous space within a patient's mouth, the form having an analogabutment protruding from the region, and the analog abutment having amodification created to ensure insertability and removability of aprosthetic within a patient's mouth’.

FIG. 1A is a schematic illustration of one preferred implant system.Referring to FIG. 1A, an embodiment of a dental implant system inaccordance with the present invention includes a one-piece universalimplant abutment device 10. In general, the universal implant-abutment10 is a single-piece device 10 including head 12, neck 14 and base 16sections. It should be noted that this device 10 is a single-piececomponent.

However, it is to be understood that the disclosure of the presentinvention may also apply to devices including one or more elements.Further, the universal implant system of the present invention may beused to treat both humans and animals alike.

The implant-abutment device 10 shown in FIG. 1A is preferably made oftitanium or titanium alloy. Alternatively, the device 10 may be made ofone or more other materials including, but not limited to, metals and/ormetal alloys, such as gold, silver, palladium, vanadium, cobalt alloy,stainless steel and the like, plastics, ceramics. Thus, by way offurther illustration, one may use one or more of the materials disclosedin U.S. Pat. No. 61068,4792 U.S. Pat. No. 5,373,621, U.S. Pat. No.5,372,660, U.S. Pat. No. 5,358,529, U.S. Pat. No. 5,354,390, U.S. Pat.No. 5,334,264, U.S. Pat. No. 5,326,362, U.S. Pat. No. 5,205,921, andU.S. Pat. No. 5,191,323, the disclosures of which are herebyincorporated by reference into this specification.

The device material should be biocompatible, nontoxic (e.g., medicalgrade) and provide sufficient strength and structural integrity whenimplanted within the jawbone of a patient.

Referring again to FIG. 1A, the height HY and diameter HX of the head 12of the implant-abutment device are approximately within the range of 1.0millimeter to about 8.0 millimeter, and 1.0 millimeer to 12.0millimeters, respectively. In one embodiment of the invention, theheight HY and diameter HX of the head are approximately 3.0 mm and 3.8mm, respectively. The associated height NY and diameter NX of the neck14 of the implant-abutment device 10 are approximately within the rangeof 0 millimeters to 8.0 millimeters and 1.0 millimeters to 12.0millimeters, respectively.

In addition, the height BY and diameter BX of the base 16 of the device10 are within the range of approximately 6.0 mm to 30.0 mm and 1.0 mm to12.0 mm, respectively.

Alternative heights and diameters can also be used provided that theoverall device dimensions permit proper implantation and functioning ofthe device 10.

As shown in FIGS. 1A and 1B, and in the preferred embodiment depictedtherein, the perimeter of the head 12 is substantially in the shape of ahexagon and includes six, planar, external main-walls 18. In oneembodiment, the six, planar main-walls 18 are interconnected by six,substantially planar, external side-walls 20. In general, the width MWof each main-wall 18 is approximately within the range of 1.0 mm to 12.0mm and the width SW of each sidewall 20 is approximately within therange of 0 mm to 12.0 mm, In another embodiment of the invention, thehead configuration includes substantially planar main-walls 18 an dnon-planar (e.g., arcuate) side-walls 20, thereby producing improvedcomfort and reduced irritation within the patient's mouth.

Alternatively, the main walls 18 may be substantially non-planar and theside walls 20 planar, or both the main walls 18 and side walls may besubstantially non-planar.

In an alternate embodiment, shown in FIG. 2, the walls 18,20 of the head12 are tapered. The walls 18,20, or portions thereof, may taper ineither radially inward or outward direction. Other configurations of thehead 12 including, but not limited to, cylindrical, triangular, square,and octagonal-shaped are also included within the scope of the claimedinvention. Additional shapes, such as those disclosed in U.S. Pat. No.6,068,479, of which the entire disclosure is incorporated by reference8, the configuration of the base 16 and threads 32 includes, but is notlimited to, those configurations as disclosed in U.S. Pat. No.5,338,197, U.S. Pat. No. 5,435,723, U.S. Pat. No. 5,564,924, U.S. Pat.No. 5,571,017, U.S. Pat. No. 5,601,429, U.S. Pat. No. 5,967,783 and U.S.Pat. No. 6,068,479; the disclosure of each of these patents is herebyincorporated by reference into this specification. The threads 32 serveto securely attach the base 16 of the implant-abutment device 10 withinthe patient's jaw. Other fastening elements including, but not limitedto, barbs, retractable barbs, one-way barbs and other textured surfacesmay also be used with the present invention.

The cylindrical base 16 of the device 10 may be solid or partiallyhollow. The structural design of the base 16 depends, in part, on thematerial or materials used to fabricate the device 10. For example, inone embodiment, a base 16 made of a semirigid material may be solid,whereas a base 16 made of a substantially rigid material may bepartially hollow. Alternatively, a base 16 made of a combination ofrigid and 5 semi-rigid materials may include solid and hollow portions.Alternate configurations of the base 16 not disclosed herein are alsoincluded within the scope of the claimed invention.

Referring to FIG. 3, a substantially cylindrical, hollow core 34 extendsthrough and along the axial length, or portions thereof, of the head 12of the device 10. The surface of the internal walls 36 of the head 12surrounding the core 34 may be threaded and slightly tapered.Alternative core 34 and surrounding wall/wall-surface designs andconfigurations including smooth, dimpled, grooved, hexagonal, polygonal,tapered, stepped, arcuate and other configurations and combinationsthereof, may also be used and are also included within the scope of theclaimed invention. In one embodiment, the hollow core 34 is adapted toreceive and securely retain a guide pin, retaining screw and/or healingball, as described in further detail below.

In alternate embodiments (not shown), the hollow core 34 extends throughand along the axial length, or portions thereof, of the head 12 and neck14, or head 12, neck 14 and base 16. In yet another embodiment, thehollow-core 34 may be off-axis and/or non-parallel to the axial lengthof the device 10.

The dental implant system of the present invention may also include ahealing ball 40, shown in FIG. 4, that can be either removably securedor permanently affixed to the universal implant-abutment device 10. Thehealing ball 40 may be made of a variety of materials and combination ofmaterials including, but not limited to, medical grade polyethylene,high-density polyethylene, K-resin, plastics, ceramics, metals andmetal-alloys. In general, the healing ball 40 may be made of anybiocompatible, non-toxic (e.g., medical grade) material that permitsproper functioning of the healing ball 40. In another embodiment of theinvention, the healing ball material may also include barium or similarelements that make the healing ball radiopaque.

Referring to FIG. 4, and in the preferred embodiment depicted therein,the healing ball 40 includes a cylindrical lower 42 portion and aspherical upper portion 44. Other healing ball configurations including,but not limited to, tooth-shaped, cone-shaped, box-shaped, donut-shaped,collar-shaped, cylindrical and spherical, may also be used with thedental implant system. In another embodiment (not shown), the healingball 40 may include one or more small holes or recesses. Theseholes/recesses may function as gripping and/oranti-rotational/antitorquing features that are engaged when tightening,removing or repositioning the healing ball within the patient's mouth.

As shown in FIG. 4, and in the preferred embodiment depicted therein, ahexagonal-shaped bore or opening 46 extends along the axial length ofthe lower portion 42 and partially along the corresponding axial lengthof the upper portion 44. The hexagonal shape of the bore 46 is used forillustration purposes and not meant to limit the invention. In general,a variety of bore shapes or configurations adapted to engage the head 12of the implant-abutment device 10 may be used with the healing ball 40of the present invention.

In the embodiment depicted, a cylindrical bore or opening 48 liesadjacent to and is aligned along the same axis of the hexagonal bore 46.The diameter of the cylindrical opening 48 may be less than, equivalentto or greater than the diameter of the hexagonal bore 46. As will bedescribed in further detail below, the cylindrical opening 48 forms alumen through the healing ball 40, thereby enabling associatedcomponents, such as a guide pin, retaining screw, cement, wax and othercomponents included within the scope ‘of the claimed invention, to beinserted therethrough. In yet another embodiment (not shown), theopening 48 may be off-axis and/or non-parallel to the axis of the device10.

In an alternate embodiment, shown in FIG. 5, the cylindrical bore 48 isremoved and the hexagonal bore 46 forms the entire opening or lumenthrough the healing ball 40. In another embodiment (not shown), thehexagonal bore 46 is removed and the cylindrical bore 48 forms theentire opening or lumen through the 11 healing ball 40. For the sake ofsimplicity of representation, references to the opening 46 of thehealing ball 40 in the remainder of this disclosure should be understoodto include opening 46 and/or opening 48.

As previously described, the opening 46 of the healing ball 40 isconfigured to match and snugly fit over the hexagonal head 12 of theimplant-abutment device 10. As such, an octagonal opening in a healingball 40 would be used for a device 10 having an octagonal head 12, atriangular opening 46 in a healing ball 40 would be used for a device 10with a triangular head 12, and so on.

In another embodiment (not shown), a reverse configuration of the mannerin which the device 10 and healing ball 40 engage each other iscontemplated. For example, the device 10 may include a recess, bore oropening into which the healing ball's 40 mating shaft, post orprotrusion is inserted. Other methods of engagement not specificallydisclosed herein but known in the art are also comprehended.

In an alternate embodiment (not shown), the opening 46 is formed of twoopposing flat surfaces or walls and two opposing arcuate surfaces orwalls. The two flat surfaces of the healing ball 40 engage two of themain-walls 18 of the implant/abutment head 12 and the two arcuatesurfaces engage the remaining main-walls 18.

Thus, in the embodiment depicted, the healing ball 40 engages the devicehead 12 in a manner similar to a conventional wrench-and-socketconfiguration. Alternate embodiments of the opening 46 including, butnot limited to, cylindrical, spherical, stepped, cylindrically-tapered,off-axis, non-parallel and other configurations not specificallydisclosed herein, are also included within the scope of the claimedinvention.

In another embodiment of the healing ball 40, the axial length of theopening 46 is approximately equivalent to the height HY of the head 12(shown in FIG. 1).

Alternatively, the length of the opening 46 may be greater than theheight HY of the head 12. In one embodiment, the base 50 of the healingball 40 surrounding the opening 46 rests upon the ledge 26 of the device10, ensuring a proper fit within the patient's mouth. In anotherembodiment (not shown), the opening of the healing ball 40 includes aninwardly-extending annular protuberance which is adapted to fit withinand is removably secured to a matching annular groove surrounding thedevice 10.

This configuration and other embodiments disclosed in U.S. Pat. No.6,068,479 (of which the specification is incorporated herein byreference) or not specifically disclosed herein are also included withinthe scope of the claimed invention.

The healing ball 40 is but one of many types of dental copings which maybe used with the device 10 of the present invention. Other types ofdental copings and/or gold cylinders including, but not limited to,those disclosed in U.S. Pat. No. 6.068,479, U.S. Pat. No. 5,733,124,U.S. Pat. No. 5,613,854, U.S. Pat. No. 51571.016, U.S. Pat. No.51476,383, U.S. Pat. No. 51439,380, U.S. Pat. No. 5.419,702, U.S. Pat.No. 51213,502, U.S. Pat. No. 51209,659, U.S. Pat. No. 5.145,371, U.S.Pat. No. 5,108,288, U.S. Pat. No. 5,040,983, U.S. Pat. No. 4.861,7672U.S. Pat. No. 4,797,100, U.S. Pat. No. 4,698,0212 U.S. Pat. No.47676.751, U.S. Pat. No. 4,492,579, U.S. Pat. No. 41459,112, U.S. Pat.No. 0.3;685,114, RE 33,796, RE 33,272, RE 33,099, and the like may alsobe used with the implant-abutment device 10. The entire disclosure ofeach of these patents is hereby incorporated by reference into thisspecification.

In one embodiment of the present invention, the healing ball 40 may beremoved from the implant-abutment device 10 prior to attachment of thedental prosthesis. As such, the healing ball 40 may serve as a temporarycover to protect the patient's tongue, inner-cheek and/or inner-lipsfrom contacting potentially rough or abrasive edges of the device 10. Inaddition, the healing ball 40 may also function as a tissue spacer, asdescribed in further detail below. Guide pins, retaining screws, wax orother attachment devices or compounds, including various combinationsthereof, may be used to temporarily attach the healing ball 40 to thedevice 10. Once the final prosthesis is available, the attachment deviceor compound and healing ball are removed and the prosthesis is securedto the implant-abutment device 10 within the patient's mouth.

In another embodiment of the invention, the healing ball 40 may bepermanently affixed to the device 10 so that the dental prosthesisdirectly attaches to the healing ball 40. For example, prostheses ordentures including metal rings, caps with rubber o-rings, ballattachment replicas and other similar fastening elements may be frictionfit over the healing ball 40 to firmly, securely and removably attachthe prosthesis to the implant-abutment device 10. As shown in FIG. 6A,one or more healing ball 40 and implant-abutment device 10 assembliesare secured within the patient's mouth. Attachment devices and compoundsincluding, but not limited to, cement, retaining screws, glues, wax,permanent soft-liner materials (such as, for example, silicone orCoesofte) and other attachment devices and compounds, includingcombinations thereof, may be used to permanently secure the healing ball13 onto the implant-abutment device 10. The fastening elements 52 of theprosthesis 54 are then friction fit over the healing balls 40 tosecurely attach the prosthesis 54 within the patient's mouth.

In an alternate embodiment, one or more tooth-shaped healing balls 40are permanently affixed to one or more devices 10 implanted within thepatient's jawbone.

As shown in FIGS. 6A and 6B, a prosthesis, denture or partial-denture 55including one or more retention clasps, rings or elements 57 aligned toengage the healing ball(s) 40 act as retaining elements to secure andstabilize the denture in the patient's mouth.

Alternate configurations of attaching the dental implant system of thepresent invention either removably or permanently to a prosthesiswell-known to those skilled in the art are also included within thescope of the present invention.

In another embodiment of the invention (not shown), bar-clipoverdentures, crowns and/or bridges (such as those disclosed in U.S.Pat. No. 5,174,954, of which the entire disclosure is hereinincorporated by reference) may be readily connected to either thehealing ball 40 and implant-abutment device assemblies or to thegold-cylinder and implant-abutment device 10 assemblies. As will beapparent to those skilled in the art, the universality of the dentalimplant system of the present invention enables it to be used inconjunction with many different types of prosthetic applications.Further, it provides the dental practitioner with substantially moreflexibility with reduced number of parts/components than the prior artsystems.

Referring to FIG. 7, the dental implant system may also include anabutment-analog 56. The abutment-analog 56 is generally a replica of thehead 12 and/or neck 14 of the implant-abutment device 10 and mainly usedin laboratory procedures during construction of patient models andprostheses. The abutment-analog includes a head 58 and neck 60 similarin design and configuration to the head 12 and neck 14 of theimplant-abutment device 10 previously described.

In one embodiment, the head 58 and neck 60 of the abutment-analog 56 areexact replicas of the head 12 and neck 14 of the implant-abutment device10.

The analog-abutment 56 may be made from a variety of materials. Examplesof such materials include, but are not limited to, brass, gold,titanium, stainless steel, metals, metal-alloys, ceramics, plastics,composites and combinations thereof are also included within the scopeof the claimed invention.

As shown in FIG. 7, the abutment-analog 56 also includes a shaft 62. Inone embodiment, the shaft 62 includes cylindrically shaped top 64,middle 66 and bottom 14 portions. The diameter of each shaft portion 64,66, 67 is variable, ranging in siz6 from approximately 1.0 mm to 10.0mm. For example, in one embodiment the top portion 64 is approximately3.0 mm, the middle portion 66 is approximately 1.75 mm and the bottomportion 67 is approximately 3.O mm. Alternatively, the top 64, middle 66and bottom 67 portions maybe approximately 1.0 mm, 3.0 mm and 1.0 mm,respectively. In general, the shaft 62 may be configured with variousgripping surfaces, projections, indentations, flat/planar portions andnon-planar portions to prevent the analog-abutment 56 from becomingdislodged from or rotating around the rigid stone or plaster materialthat forms the final model for the prosthesis, as described in furtherdetail below.

Referring to FIGS. 8 and 9, the dental implant system of the presentinvention may also include a retaining screw 68 and guide pin 70,respectively. Referring to FIG. 8, the retaining screw 68 is used tosecure the healing ball 40 and/or prosthesis, either permanently ortemporarily, onto the implant-abutment device 10.

As such, the threaded portion 72 of the retaining screw 68 is configuredto engage the threads on the surface of the internal walls 36 of thedevice 10. In general, the retaining screw may be approximately 2.0 mmto 10.0 mm in length. In one embodiment, the diameter of the head 74 ofthe retaining screw 68 may be configured to seat within the lumen of thehealing ball 40. Alternatively, the head 74 may be seated on theexternal surface of the healing ball 40. The retaining screw 68 may bemade of a variety of biocompatible, non-toxic materials including, butnot limited to, brass, gold, titanium, stainless steel, metals,metal-alloys, ceramics, plastics, composites and combinations thereof.

The guide pin 70, shown in FIG. 9, is used to secure the healing ball 40to the implant-abutment device 10 for taking final impressions of theposition of the head 12 of the device 10. The length of the guide pin 70is approximately within the range of 3.0 mm to 20.0 mm. In general, theguide pin 70 is configured so that a sufficient portion of the head orshaft 76 extends outside of the healing ball 40, enabling a user orpractitioner to firmly and securely grip the guide pin 70. The shaft 76may be made of a variety of shapes and surface configurations including,but not limited to, cylindrical, conical, polygonal, ribbed, dimpled,smooth and textured.

As with the retaining screw 68, the threaded portion 78 of the guide pin70 may also be configured to engage the threads on the surface of theinternal walls 36 of the 15 device 10. In addition, a variety ofbiocompatible, non-toxic materials may be used to fabricate the guidepin 70 of the present invention. Examples of these materials include,but are not limited to, brass, gold, titanium, stainless steel,’ metals,metal alloys, ceramics plastics, composites and combinations thereof arealso included within the scope of the claimed invention.

Although the retaining screw 68 and guide pin 70 are shown in FIGS. 8and 9, respectively, to include a slotted head, other headconfigurations known in the art to either manually or mechanically drivethe screw 68/guide pin 70 into the device 10 may also be used and areincluded within the scope of the claimed invention. One or more of theuniversal implant-abutment device 10, healing ball 40, abutment-analog56, guide pin 70 and retaining screw 68 components of the dental implantsystem of the present invention may be packaged together to form a kit(not shown). The size, material, shape and configuration of eachcomponent compliments the other components, thereby assuringcompatibility, interchangeability, durability and perfect fit. Inaddition, component parameters, such as size, material, shape andconfiguration of each component for either single or multiple toothreplacement kits, may be the same or variable within each kit.

Each kit may be configured to provide the necessary components for aparticular procedure. For example, in one embodiment of the invention,the kit for a single-tooth replacement procedure may include one implantabutment device 10, three healing balls 40, one analog abutment 56, oneretaining screw 68 and one guide pin 70. In another embodiment, asingle-tooth replacement kit may include two implant abutment devices10, six healing balls 40, two analog abutments 56, two retaining screws68 and two guide pins 70. In an alternate embodiment, a multiple-toothreplacement kit may include three implant abutment devices 10, ninehealing balls 40, three analog abutments 56, three retaining screws 68and three guide pins 70. Other kit configurations not disclosed hereinbut known in the art are also included within the scope of the claimedinvention.

Many methods of using the universal implant system of the presentinvention are contemplated herein. Each methodology is related to theparticular type of dental reconstruction required by the patient'scondition. The following methods are intended as example and forillustration purposes only and are not meant to limit the claimedinvention.

In one embodiment, a mid-crestal and reverse bevel labial incision 80 ismade extending along two teeth and on both sides of the edentulousspace, as shown in FIG. 10. A similar incision is made palatally,resulting in —a full thickness envelope flap 82 as shown in FIG. 11.

Referring to FIG. 12, a hole 84 is then drilled within the jawbone ofthe patient. The exact point of purchase and approach, either cingulumor labial, within the edentulous space and jaw anatomy are visuallydetermined. In general, the approach should be one that will provide thegreatest amount of stability for the device 10, and, generally, isparallel to the long axis of adjacent teeth.

One or more drill bits used at variable speeds with sufficientirrigation create the appropriately sized and shaped hole 84. The depthof the hole 84 is sized to receive the base 16 of the implant-abutmentdevice 10, and generally ranges from approximately 8 mm to 30 mm indepth.

Referring to FIG. 13, the implant-abutment. device 10 is then manuallyinserted into the hole 84 in a sterile manner. In one embodiment, acarrier (not shown) may be used to deliver the implant-abutment device10 to the hole 84 and also to begin manually screwing the device 10 intothe hole 84. An example of such a carrier is disclosed in U.S. Pat. No.6,068,479, of which the entire disclosure in incorporated herein byreference. Other carriers and similar tools not specifically disclosureherein but known in the art may also be used and are included within thescope of the claimed invention.

Generally, only a portion of the base 16 of the implant-abutment device10 can be manually inserted into the hole 84. A power-drivensocket-wrench, contra-angle handpiece or similar tool may be used tofully seat the device 10 within the hole 84.

Crestal bone height and clinical parameters such as device stability,tissue thickness as required for prosthesis aesthetics andinter-occlusal distance may also be taken into consideration todetermine final position and configuration of the device 10.

The gingival tissue and flaps 82 are inspected, trimmed, coapted andsutured around the head 12 of the device 10. Factors, such as amount oftissue recession after healing, final crown space required and/or otheraesthetic and prosthetic considerations, may be taken into account withrespect to tissue placement and suturing.

Either immediately after suturing or anytime thereafter, the prosthesismay be attached to the device 10. No further surgical procedures arerequired, unlike prior art processes which often require a second stagesurgery to expose and prepare a gingival seat around the device andperform other modifications to ensure proper prosthetic-deviceengagement. As previously described, with prior art devices andprocedures, a space or recess between the device and. soft tissue mustbe created to allow an appropriate interface and ensure proper placementof the prosthesis without trapping soft tissue. In contrast, theprosthesis may be directly attached to the implant-abutment device 10 ofthe present invention without further surgical intervention.

Referring to FIG. 14, a healing ball 40 may be attached to the device 10to contour the tissue for proper impression registration. In oneembodiment of the invention, the healing ball 40 is attached directlyafter tissue suturing and prior to hard and soft tissue healing. Aretaining screw 68 or similar component previously described may be usedto secure the healing ball 40 onto the device 10. The healing ball 40 isthen left in place for an approximately seven to ten day time period.

Alternate time periods that allow the soft tissue to mature and form astable recess for the prosthesis may also be used.

After the soft tissue has matured and formed a stable recess, a finalimpression may be taken from which the prosthesis is created. Theoriginal healing ball 40 is removed, and another, interchangeablehealing ball 40 is secured to the device 10 with a guide pin 70.Alternatively, the original healing ball 40 is left in place and theretaining screw 68 is replaced with a guide pin 70.

As shown in FIG. 15, an impression tray 86 with a window or opening 88is placed over the healing ball 40 within the patient's mouth. Theopening 88 of the tray 86 is aligned with the guide pin 70 so that theguide pin 70 protrudes above the impression frame. The guide pin 70holds the healing ball 40 in place during setting of the impressionmaterial. After the material is set, the protruding portion of the guidepin 70 is used to unscrew the guide pin 70 from the healing ball 40 andremove the guide pin 70 through the tray opening 88. The healing ball 40is then transferred with the impression material when the impressiontray 86 is removed from the patient's mouth, as shown in FIG. 16. Theoriginal healing bal-I 40 may be re-attached to the device 10 as aprotective covering and tissue spacer.

In an alternate embodiment, anti-rotational grooves, indentations orother types of gripping features may be formed on the healing ball 40.These features prevent movement or displacement of the healing ball 40within the impression material when the healing ball/impression tray areremoved from the patient's mouth.

Referring to FIG. 17, and in the process depicted therein, ananalog-abutment 56 is inserted into the matching cavity of the healingball 40 contained within the impression material. As previouslydescribed, the analog-abutment 56 replicates the configuration of theimplant abutment device 10 of the present invention. With theanalog-abutment 56 seated in the healing ball 40, an impression is thenpoured in a rigid stone or plaster material to form the final model 90.In general, the entire analog-abutment 56, excluding its head 58 or head58 and neck 60, may be buried in the final working model 90. As such,the remaining exposed portion of the analog-abutment 56, together withthe impression material, forms an accurate and visible replica of theedentulous space within the patient's mouth prior to restoration, asshown in FIG. 18.

Referring to FIG. 19, a healing ball 40, coping (such as a preformedcoping in the shape of a healing ball 40, tooth or other shapes) ormetal framework may be used as part of the final prosthesis 92. Some ofthe materials used to form the final prosthesis include, but are notlimited to, metal, metal alloys, ceramics, composites, aluminum oxide,fiber core, zirconium and other materials. The final prosthesis 92 maybe formed using a lost wax technique, laser scan generated images,optical impression, CAD/CAM manufacturing, reverse engineering, rapidprototyping and other conventional techniques or methods. Once complete,the final prosthesis 92 is then installed within the patient's mouthusing cement, retaining screws, or other attachment means known to thoseskilled in the art.

In an alternate embodiment (not shown), two or more implant-abutmentdevices 10 may be used for a single tooth (e.g., molar) restoration. Theuse of multiple implant-abutment devices 10 for a single toothrestoration provides greater support and stability for the finalprosthesis. In addition, this configuration provides improvedosseointegration and greater device surface area, which also improvesthe retentive strength of the prosthesis.

A multiple tooth or full-mouth reconstruction method of the presentinvention is similar to the single tooth reconstruction method. However,as previously described, multiple tooth or full-mouth reconstructionprocedures are more involved, requiring common paths of insertion,sufficient friction to ensure a firm fit and no undue soft tissuetension.

In one embodiment, the incision 80, hole 84 and implant-abutment device10 insertion are made in a manner similar to that previously describedfor the single tooth reconstruction method. However, the approach ismodified to accommodate multiple restorations. For example, the incision80 may be larger, multiple holes 84 are generally created within thejawbone of the patient, and, likewise, multiple implant abutment devices10 are inserted within the holes 84, as generally shown in FIG. 20. Thefour-teeth reconstruction shown in FIG. 20 is for illustration purposesand not meant to limit the scope of the claimed invention.

After adequate soft tissue healing has occurred and a stable recess forthe prosthesis has been formed using healing balls 40 as previouslydescribed, the temporary prosthesis or original healing balls 40 areremoved from each device 10.

In one embodiment, a pattern resin or similar material may be used tolute or connect all the healing balls 40 together as one unit, forming acoping framework. This process may be used for both the original healingballs 40 and the new healing balls 40.

Next, an impression is taken using an appropriately sized impressiontray 86.

The protruding portions of the guide pins 70 extend through theopening(s) 88 in the impression framework, as shown in FIG. 21.Alternatively, a traditional disposable stock tray (not shown) may beused. As such, after all the healing balls 40 are luted or splintedtogether thereby forming a “picket-fence” type effect, the guide pins 70can be removed from the healing balls 40. The healing balls 40 willremain in position and form a stable framework due to the “picket-fence”effect and remain in proper alignment with each other. Impressionmaterial can then be injected under and around the healing balls 40.

After the impression material has set, the guide pins 70, tray 86 andimpression material are removed from the patient's mouth. The resultingimpression includes the healing balls 40 incorporated in the impressionmaterial. The low height or minimal profile of the head 12 of eachdevice 10 and flexibility of the impression media allow an accurateimpression to be made, without permanent distortion or damage. Inparticular, the healing balls 40, as integral parts of the impression,may be cleanly withdrawn from the devices 10 without disturbing theprecise relationship of each 20 device 98. The other devices 10 are thenmodified (e.g.. portion 100, shown in the FIG. 24 as encircled by adashed line, is removed) according to the inclination/alignment of thesedevices 10 in relationship to the reference device 98 to ensure a secureand accurate fit for the final prosthesis.

Healing balls 40, copings or metal frameworks are then installed on themodified heads 58 of the stone model 94 and may be used as part of thefinal prosthesis. As previously described, the final prosthesis may beformed using a lost wax technique, laser scan generated images, opticalimpression, CAD/CAM manufacturing, reverse engineering, rapidprototyping and other conventional techniques or methods.

With the final stone model 94 as a guide, the corresponding surfaces ofthe device heads 12 in the patient's mouth are removed. After a passiveplacement is achieved, the final prosthesis is then installed usingcement, retaining screws or other attachment means to stabilize andsecure the prosthesis within the patient's mouth.

In an alternate embodiment of the invention, a template (not shown)together with the final stone model 94 is used as a guide for removingthe necessary portions/surfaces of the device heads 12 in the patient'smouth. The template may be one or more copings, caps, framework or othertypes of coverings linked or connected together to maintain alignment ofthe caps to each other and to their counter-part analog-abutments 56 inthe final stone model 94. The template may be made of a variety ofmaterials including, but not limited to, metals, metal alloys, plastics,ceramics, composites and other materials, including combinations ofmaterials.

Further, each cap may be a variety of configurations (such as, forexample, cylindrical, spherical, hexagonal, polygonal and otherconfigurations), provided the cap configuration matches to securelyengage its corresponding analog-abutment configuration.

The following example and associated figures will reference only asingle cap in a template and a single analog-abutment 56 in a finalmodel 94, however it is understood that the template and final model 94include one or more caps and analog abutments 56, respectively.

As previously disclosed, the cap of the template replicates itscounterpart head 58 of the analog-abutment 56 in the final model 94.Referring to FIG. 25, a portion 100 (shown in phantom on FIG. 25) of theanalog-abutment head 58 in the final model 94 is removed or modified aspreviously described. The corresponding portions 22 of its matching cap104 are then also removed, forming a window or some other type ofopening 104 in the cap 102 that corresponds to the modified area of thehead 58, shown in FIG. 26.

As shown in FIG. 27, when the cap 102 is properly positioned or placedover the patient's corresponding implant-abutment device 10, portions ofthe device 10 protruding through the opening 104 correspond to theremoved portions of the analog abutment 100. At this point, the user mayuse an appropriate tool to remove the protruding portions of the device10. Alternatively, the user may simply mark the portions of the device10 that need to be modified, remove the cap and then remove/modify themarked portions of the device 10. Other methods of modifying the device10, including the cap 102, not specifically disclosed but known in theart may also be used.

The quantity of components and associated reconstruction methods of thedental implant system of the present invention are greatly reduced andsimplified compared to conventional implant systems and methods of use.Especially in multiple implant situations, the dental implant system ofthe present invention greatly reduces the number of clinical proceduresand total treatment time. In particular, the amount of time between theinitial surgery to the tooth/prosthesis mounting is greatly reduced.

Further, the procedures or methods of the present invention are alsomore predictable with respect to cosmetic and functional effects of thefinal prosthesis when compared to traditional approaches. As such, thedental implant system of the present invention may reduce post-operativeinfection, improve device/prosthesis strength and prolong its stabilityand reduce the overall time for a reconstruction procedure byapproximately three months or more. In addition, the dental implantsystem and associated methods of the present invention enable apractitioner to form a final prosthesis, including an infinite number offacsimiles of said final prosthesis (for example, as spares orreplacements if the original prosthesis should become damaged or lost),based on a single impression. In general, the overall procedure usingthe dental implant system of the present invention is fast, simple andeffective.

FIG. 28 is a partial exploded view of an dental implant assembly 200comprised of a head 202 which facilitates the use of assembly 200 inmultiple implant restorations.

Referring to FIG. 28, and in the preferred embodiment depicted therein,it will be seen that head 202 is comprised of sides 204, 206, 208, 210,and 212. Each of these sides intersects with surface 214 of neck 14.

In one embodiment, illustrated in FIGS. 34A and 34B, the neck 14 isomitted and the head 202 is directly contiguous with base 16.

Referring again to FIG. 28, and in the preferred embodiment depictedtherein, with the exception of side 208, each of the other sides formsan angle vis-{dot over (a)}-vis surface 214 that is substantiallyperpendicular, ranging from about 80 to about 100 degrees and, morepreferably, from about 75 to about 95 degrees. However, the side 208forms an angle with surface 214 of less than about 75 degrees.

In the embodiment depicted in FIG. 28, there are at least five sidesthat intersect surface 214 at a substantially perpendicular angle.Devices with more of such sides may be used, provided that at least twosides of the head 202 are substantially perpendicular to the surface 214and at least one side forms an angle with such surface of less thanabout 75 degrees. In one embodiment, at least three such sides of thehead 202 are substantially perpendicular to the surface 214. In anotherembodiment, at least four such sides of the head 202 are substantiallyperpendicular to the surface 214. In yet another embodiment, at leastfive such sides of the head 202 are substantially perpendicular to thesurface 214.

In another embodiment, not shown, at least two of sides of the head 202form an angle of from about 60 to about 100 degrees with the surface214.

Referring again to FIG. 28, a bore 216 extends from the top surface ofthe head 202 to a distance of from about 2 to about 5 millimeters. Inone embodiment, the bore 216 is threaded.

In another embodiment, not shown, the bore 216 is omitted from the head202. In another embodiment, not shown, the bore 216 is replaced by anannular groove disposed beneath substantially polygonal portion of head202 and surface 214. In one embodiment, the bore 216 is substantiallycoaxial with the axis 220 of base 16. In another embodiment, illustratedin FIG. 28, the bore 216 is not coaxial with the axis 220 but, instead,forms an angle that is less than 45 degrees and, in one embodiment, issubstantially identical to the angle formed by side 208 with surface214.

FIGS. 28A and 29A disclose a dental implant assembly 201 which issimilar to the assembly 200 but differs therefrom in that the bore 216is substantially perpendicular to the axis 220.

FIGS. 28B and 29B disclose a dental implant assembly 203 which issimilar to the assembly 200 but differs therefrom in that the bore 216is substantially parallel to the axis 220. In the embodiment depicted,bore 216 is also substantially coincident with the axis 220.

Referring again to FIG. 28, it will be seen that a healing ball 205 isadapted to fit over the head 202. A similar healing ball 205 may be usedin the embodiments depicted in FIGS. 28A and 28B but has been omittedtherefrom for the sake of simplicity of representation.

The shape of the head depicted in FIGS. 29A and 29B may be varied. Someother suitable shapes are depicted in FIGS. 30A through 30H.

FIGS. 30A through 30H present a multiplicity of sectional views showingthe shapes in which the head 202 may be. In the embodiments depicted,the shapes are either comprised of straight walls 230 and/or arcuatesections 232.

FIGS. 31A and 3B are perspective and top views, respectively, of anassembly 240 in which arcuate section 242 joins walls 244 and 246 ofinclined section 208. As will be apparent, because arcuate section 242theoretically contains an infinite number of walls, the structure 240meets the requirement that at least two such walls are substantiallyperpendicular to the surface 214 of base 16.

FIGS. 32 disclose an exploded view of an assembly 250 that is similar inconfiguration to the assembly 240 but differs therefrom in that arcuatesection 242 is comprised of a multiplicity of splines 252. In theconfiguration depicted in FIG. 32, such splines 252 have a substantiallyrectangular cross-sectional shape.

Referring again to FIG. 32, and in the preferred embodiment depictedtherein, it will be seen that healing ball 254 preferably is comprisedof an orifice 256 that is adapted to receive the section 208 and thesplines 252.

FIG. 32A is a partial sectional view of a implant assembly 207 that issimilar to the implant assembly 201 (see FIG. 28A) but omits that omitsthe orifice 216.

FIG. 32B is a partial sectional view of an implant assembly 209 that issimilar to the implant assembly 201 (see FIG. 28A) but differs therefromin that it does contain an orifice 216 that is substantially alignedwith the axis of the device 209.

As will be apparent from FIGS. 33A through 33H, different splinedarrangements may be used with the device 250.

Thus, as depicted in FIG. 33A, the splines 252 may have a substantiallyrectilinear cross-sectional shape. As depicted in FIG. 33B, the splines256 may have a substantially triangular cross-sectional shape. Asdepicted in FIG. 33C, the splines 258 may have a substantially circularcross-sectional shape. As depicted in FIG. 33D, the splines 260 may havea substantially polygonal cross-sectional; in the embodiment, depicted,this shape is formed by alternating rectangles and triangles. Asdepicted in FIG. 33E, the splines 262 may have a shape defined by alinear section and an arcuate section; in the embodiment depicted, thesplines 262 are formed by alternating semicircles and flat surfaces. Asdepicted in FIG. 33F, the splines 264 may have different shapes whichmay alternate on the splined surface; thus, e.g., they may contain bothtriangular, circular, and composite shapes in which flat top intersectstwo adjacent splines. The splines 266 depicted in FIG. 33G are definedby half-circles joined by arcuate tops. By comparison, the splines 268depicted in FIG. 33H are defined by triangular sections joined byarcuate tops. Many other splined shapes, not shown, also may be used.

FIG. 35 is a perspective view of an implant assembly 270 that similar tothe implant assembly 269 of FIGS. 34A and 34B but differs therefrom inthat the surface 272 of base 16 is roughened.

In one embodiment, the surface 272 is roughened in accordance with theacid-etching procedure disclosed in International patent publication WO96/16611. In the process described in this patent publication, thesurfaces of the implant body are exposed to an acidic etching processafter the natural titanium oxide layer is removed to attain anessentially uniform roughness over the entire surface (WO 96/16611).applicant's U.S. Pat. No. 5,733,124, the entire disclosure of which ishereby incorporated by reference into this specification.

In another embodiment, the surface 272 is roughened in accordance withthe procedure disclosed in an article by Cochran et al., “Bone responseto unloaded and loaded titanium implants with a sand-blasted andacid-etched surface”, Journal of Biomedical Materials Research, Vol. 40,1998, p.1. In this process, the surface 272 is subjected to coarse sandblasting to create macroroughness in the titanium. This process isfollowed by acid etching that generates evenly-distributed micropits inthe sand-blasted surface.

One may roughen such surface 272, or other surfaces, by conventionalmeans known to those skilled in the art. Thus, e.g., one may use theroughening processes disclosed in U.S. Pat. Nos. 5,588,838 of Hannson(microroughness having a height between 0.02 to about 0.2 millimeters),5,607,480 of Beaty (individual depressions and dents with transversedimensions about half of the size of impacting grit particles, on theorder of 5–10 microns), 5,947,735 (additive and subtractive roughening),5,897,027 of Wagner et al. (surface roughness of from about 7 t to about300 microinches), 6,344,061 of Leitao et al. (surface roughness with anaverage peak distance between 10 and 1,000 nanometers), 6,095,817 ofWagner et al., and the like. The entire disclosure of each of theseUnited States patents is hereby incorporated by reference into thisspecification.

One preferred means for providing the desired degree(s) of roughness tothe implant assembly of this invention is described below. The processdescribed below is especially advantageous for use with one-pieceimplant assemblies.

In this process, all abutment areas are preferably completely covered bysoft wax to get a demarcation and to protect the abutment portion of theone piece implant from sandblasting and etching.

Waxing of the implant abutment assembly involves insertion of a guidepin into orifice 216 (see FIG. 36). The implant assembly is then placedinto a pre-drilled Pro-form laminate plate Wax is then heated on a hotplate to a temperature sufficient to melt the wax and liquefy it.

A masking device, such as a plate, is used to separate and isolate thetop part of the implant assembly from its bottom part. The plate ispreheated to a temperature of about 70 degrees Centigrade for about 10minutes. Thereafter, wax is poured over the masked implant assembly andallowed to cool for from about 30 to about 45 minutes.

Thereafter, the assembly is cooled in a refrigerator for from about 10to about 15 minutes. The partially masked implant assembly that ispartially embedded in wax is then subjected to sandblasting.

Thereafter the exposed portion(s) of the one-piece implant assembly isgrit blasted using a Renfert sandblaster with non-recycled aluminumoxide (50 micron size) to remove burrs and metallic contaminants. Thesand-blasted assembly is then subjected to acid etching.

In one embodiment, acid etching is accomplished with the use of an acidsolution composed of a 10–30 volume percent (150–450 g/l) of 70% nitricacid and 1:3 volume percent (12 to 36 g/l) of 48% hydrofluoric acid(maintaining a ratio of 10 parts nitric acid to 1 part hydrofluoricAcid). The surface of the implant assembly to be acid etched iscontacted with the acid mixture while being subjected to ultrasonicenergy for 3 minutes.

FIGS. 37A and 37B illustrate two preferred devices which may be made bythe process of this invention. Referring to these Figures, it will beseen that each of implant assemblies 300 and 302 is comprised of basesection 304, and ledge section 320, and head section 308.

In each of implant assemblies 300 and 302, the base section 304, theledge section 320, and the head section 308 are integrally joined toeach other.

In each of implant assemblies 300 and 302, the head section 308 has across-sectional shape formed by alternating arcuate and linear walls;similar devices are disclosed in U.S. Pat. No. 5,733,124, the entiredisclosure of which is hereby incorporated by reference into thisspecification.

Referring to implant assembly 300, one of the linear walls is wall 301,and the arcuate walls are walls 303 and 305.

Referring to implant assembly 302, the linear wall is wall 307, and thearcuate wall is wall 309.

Each of implant assembles 300 and 302 is comprised of a base 304 thatextends upwardly and outwardly from its bottom 310 to its top 312.

In the preferred embodiments depicted in FIGS. 37A and 37B, the base 304is preferably comprised of two distinct sections. The first such section312, extending from point 314 to point 316, has a length 318 of fromabout 3 to about 50 millimeters and, preferably, from about 7 to about17 millimeters. The second such section 320, extending from point 314 topoint 322, has a width 324 of from about 0.0 to about 2 millimeters and,preferably, from about 0.3 to about 0.7 millimeters.

It is preferred that section 320 have a width 324 that is no greaterthan about 15 percent of the length 318 of section 312 and, morepreferably, is less than about 10 percent of the length 318 of section312.

In both of the embodiments depicted in FIGS. 37A and 37B, the section312 has a substantially rougher surface than the section 320.

FIG. 38 is a sectional rough of a roughened surface 350 formed in asubstrate 352. As will be seen, this roughened surface 350 is comprisedof a multiplicity of peaks 354 and valleys 356. The distances 360, 362,364, 366, 368 between the peaks 354 and the valleys 356 indicate theroughness of surface 350. For the purposes of this specification, theroughness of any such surface is the average peak-to-valley distance ofthe surface. As is known to those skilled in the art, this may bemeasured by conventional techniques, such as, e.g., scanning electronmicrography.

Referring again to FIGS. 37A and 37B, and in the preferred embodimentdepicted therein, the section 312 will preferably have an averageroughness (i.e., an average peak to valley distance of its indentations)of from about 10 to about 1,000 microns and, preferably, from about 20to about 200 microns.

In this embodiment, the section 320 will preferably have an averageroughness (i.e, an average peak to valley distance of its indentations)of from about 0.1 to about 100 microns.

The section 312 will preferably have an average roughness that is atleast about 10 times as great as the average roughness of the section320. In one embodiment, the section 312 has an average roughness that isat least about 50 times as great as the average roughness of section320. In another embodiment, the section 312 has an average roughnessthat is at least about 100 times as great as the average roughness ofsection 320.

One may obtain the differential roughness properties describedhereinabove by subjecting the sections 312 and/or 320 to differenttreatments and/or different lengths of treatment, masking one (with wax,e.g.) while treating another. Thus, for example, the section 312 may betreated with both sandblasting and acid etching, whereas the section 320may be subjected to micromachining or laser etching.

Thus, e.g., one may use microtexturing to create the roughness insection 320. Reference may be had, e.g., to U.S. Pat. Nos. 6,228,434,5,964,804, 5,782,912, 5,349,503, 5,909,020, and the like. The entiredisclosure of each of these United States patents is hereby incorporatedby reference into this specification.

Thus, e.g., one may use laser etching to create the roughness in section320. Reference may be had, e.g., to U.S. Pat. Nos. 5,164,324, 6,391,212,6,277,312, 5,544,775, 5,018,164, and the like. The entire disclosure ofeach of these United States patents is hereby incorporated by referenceinto this specification.

In one embodiment, illustrated in FIGS. 37A and 37B, the roughenedsurface 312 is coated with a bioactive coating 370. The biologicalcoating 370 is comprised of or consists essentially of a biologicalactive material.

As is disclosed in U.S. Pat. No. 6,344,061, the substrate having thedesired surface roughness can efficiently be coated in vitro with alayer of one or more biologically active agents; the entire disclosureof this United States patent is hereby incorporated by reference intothis specification. . The composite coating can be relatively thin, inthe order of from, e.g. 50 nanometers to 200 microns, especially from 1to 50 microns. The biologically active agent in the coating includes,but is not limited to, single or combinations or proteins, lipids,(lipo)polysaccharides, growth-factors, cytostatic agents, hormones, andantibiotics. Examples of such agents are bone morphogenetic proteins(BMP's), basic fibroblast growth factor (bFGF), transforming growthfactor (TGF-β), osteogenic growth peptide (OGP), et cetera. Themolecular weight of said biologically active agents can vary fromseveral tens of Daltons, to thousands of kilo-Daltons.

In one embodiment, at least a portion of the coated layer has athickness greater than the average depth of the roughened surface. See,e.g., U.S. Pat. No. 6,344,061.

In another embodiment, the biologically active agent is selected fromthe group consisting of proteins, lipids, (lipo)polysaccharides, growthfactors, cytostatic agents, hormones, antibiotics, and combinationsthereof. See the aforementioned U.S. Pat. No. 6,344,061.

In yet another embodiment, the biologically active agent is selectedfrom the group consisting of bone morphogenetic proteins, basicfibroblast growth factor, transforming growth factor, osteogenic growthpeptide, and combinations thereof. See U.S. Pat. 6,344,061.

In one embodiment, the coating is comprised of one or more anionsselected from the group consisting of hydroxide, chloride, sulphate,nitrate, and combinations thereof. In another embodiment, the coatingfurther comprises one or more cations selected from the group consistingof hydrogen, sodium, potassium, magnesium, and combinations thereof.See, e.g., such U.S. Pat. No. 6,344,061.

In yet another embodiment, the sandblasting step is replaced by blastingwith other abrasive material, such as alumina.

In yet another embodiment, the biologically active material is comprisedof organic material comprising a multiplicity of amino acids and/orproteins.

In one embodiment, the organic material is an organic amine containingfrom about 1 to about 10 carbon atoms and from about 1 to about 4 aminogroups. Some suitable materials in this embodiment includegamma-aminopropyletriethyoxysilane, allyl amine, carebodiimide, bonemorphogenic protein, extracellular matrix proteins, and the like.Reference may be had, e.g., to articles by Wojcik et al. (“Biochemicalsurface modification . . . for the delivery of protein . . . , ” BiomedSc Instrum 1997;33: 166–171), by Puleo et al. (“A technique to immobilebioactive proteins . . . , ” Biomaterials 2002 May; 23(9): 2079–2087),by An et al. (“Prevention of bacterial adherence to implant surfaces . .. , ” J Orthop Res 1996 Sep; 14(5):846–849), by Bessho et al. (“BMPstimulation of bone response . . . ,” Clin Oral Implants Res 1999 Jun;10(3):212–8), by Deligianni et al. (“Effect of surface roughness of thetitanium alloy . . . , ” Biomaterials 2002 Jun; 22(11): 1241–1251), byDean et al. (“Firbonectin and laminin enhance gingival cell attachment .. . , ” Int J. Oral Maxillofac Implants 1995 Nov–Dec; 10(6):721–728), byKeogh et al. (“Albumin binding surfaces for biomaterials,” J Lab ClinMed 1994 Oct; 124(4):537–545), and the like. The disclosure of each ofthese publications is hereby incorporated by reference into thisspecification.

In one embodiment, the biologically active material is coated onto arelatively smooth section 312 and/or 320 in order to form the roughenedsurface. As will be apparent, either the roughed surface, and/or thecoated surface, will tend to promote adhesion between the implantassembly and the biological tissue surrounding it.

One means of facilitating such adhesion is to impart a charge to one ormore of the implant surfaces. Thus, e.g., one may incorporate anionsand/or cations into or onto such surface, as is disclosed in such U.S.Pat. No. 6,344,061. Thus, e.g., one may incorporate charged moietiesinto or onto such surface by the process disclosed in an article by P.S. Chockalinagm et al. entitled “DNA affinity chromatography,” J. MolBiotechnolgy 2001 Oct 19(2): 189–199.

In one embodiment, protein is coupled to silanized titanium withgluaraldehyde. See, e.g., the article by Wojcik et al., “Biochemicalsurface modification . . . ,” Biomed Sci Instrum 1997; 33: 166–171.

Referring again to FIGS. 37A and 37B, and in the preferred embodimentsdepicted therein, it will be seen that head section 308 extends adistance 323 above the top surface 325 of ledge 322 of from about 2 toabout 8 millimeters and, preferably, from about 2 to about 4millimeters.

The implant assembly of this invention may be used in the processdisclosed in U.S. Pat. No. 6,068,479 and, in particular, in the FIG. 18depicted therein; the entire disclosure of such U.S. Pat. No. 6,048,479is hereby incorporated by reference into this specification.

Thus, e.g., referring to such U.S. Pat. No. 6,048,479 and, inparticular, to the FIG. 18 thereof, in the first step of this process,step 300, abutment 10 is connected to implant fixture 114.

In this step, it is preferred to apply a torque no greater than about 20Newton/centimeter.

Thereafter, in step 302 of the process, a hole is drilled in the jawboneof the patient sufficiently deep to receive only the length of theimplant fixture. In general, this hole is usually from about 8 to about18 millimeters.

Thereafter, in step 304 of the process, the hole thus drilled ispreferably tapped with a tapping tool such as, e.g., the screw tapsillustrated on page 11 of the Nobelpharma catalog.

Thereafter, in step 306 of the process, the abutment/implant fixtureassembly is delivered to the hole by means of the carrier 90. Thecarrier 90 may also be used to start screwing the assembly into thehole, applying downward pressure while turning the assembly.

Generally, the carrier 90 will only enable one to drive theabutment/implant fixture assembly a portion of the required distance.The job may be finished by a power-driven socket wrench in step 308 ofthe process.

In the next step of this preferred process, step 310, the healing ball160 is preferably snapped onto the abutment 10. In one preferredembodiment, the healing ball 160 is disposed within compartment 101 ofcarrier 90 prior to its use.

Thereafter, in step 312, the gum tissue where the hole had been drilledis sutured around the healing ball 160.

In the next step of process, step 314, the surgical site is allowed toheal before the abutment 10 is directly or indirectly connected to adenture. In general, a healing period of from about 3 to about 6 monthsis desirable.

After the desired time of healing, no additional surgical procedure isrequired, unlike the prior art process (which necessitated second stagesurgery to remove the cover screw used in the process and to attach theprosthetic abutment). By comparison with prior art processes,applicant's prosthetic abutment is already attached.

At this stage of applicant's process, several options are available. Inone embodiment, illustrated in step 316 of U.S. Pat. No. 6,068,479, thehealing ball is attached directly to a denture into which metal capswith an O-ring have been cured.

In another embodiment, illustrated in step 318, the healing ball 160 isremoved from the abutment 10. At this stage, several additional optionsare available.

One such option is to attach the gold cylinder 190 on the abutment 10 instep 320. Once the gold cylinder 190 has been so attached, one mayprepare a bar clip overdenture (see FIG. 12) and attach such denture tothe superstructure (see step 322). Alternatively, in step 324, the goldcylinders 190 can be incorporated into a fixed detachable implantsupported bridge and thereafter secured to multiple implants in place inthe jawbone.

Alternatively, in step 326, after the healing ball 160 has been removeda gold coping 210 may be attached to a tooth where such a gold coping isimbedded in the tooth). Thereafter, in step 328, such tooth is attachedto the abutment 10.

It is to be understood that the aforementioned description isillustrative only and that changes can be made in the apparatus, in theingredients and their proportions, and in the sequence of combinationsand process steps, as well as in other aspects of the inventiondiscussed herein, without departing from the scope of the invention asdefined in the following claims.

1. A dental implant assembly comprised of an integral dental implant,wherein said integral dental implant is comprised of an abutment head animplant body, and a neck section comprised of a ledge, wherein saidledge section is disposed between, and integrally joined with, saidabutment head and said implant body wherein: (a) said abutment head iscomprised of top section and a bottom section integrally joined to saidtop section, wherein: i. said top section has a shape formed by a linearwall adjacent to an arcuate wall, ii. said abutment head has a length offrom about 2 to about 4 millimeters iii. said bottom section isintegrally joined to said neck section; (b) said implant body iscomprised of a top section and a bottom section, wherein said implantbody extends upwardly and outwardly from said bottom section to said topsection wherein said top section is integrally joined to said necksection; wherein: i. said implant body has a length of from about 3 toabout 20 millimeters, and the surface of said implant body has anaverage irregular roughness of from about 10 to about 1,000 microns, ii.said neck section has a length of from about 0.1 to about 2 millimeters,and the surface of said neck section has an average roughness of from0.1 to about 100 microns, iii. said length of said neck section is lessthan about 15 percent than said length of said implant body, and iv.said average irregular roughness of said implant body is at least about10 times as great as said average roughness of said neck section.
 2. Thedental implant assembly as recited in claim 1, wherein said abutmenthead is comprised of an orifice extending through a portion of said topsection of said abutment head.
 3. The dental implant assembly as recitedin claim 2, wherein said top section of said abutment head has across-sectional shape substantially like a polygon.
 4. The dentalimplant assembly as recited in claim 3, wherein said ledge is ahorizontally-extending ledge.
 5. The dental implant assembly as recitedin claim 4, wherein said abutment head is comprised of a base whichextends upwardly and outwardly from its bottom to its top.
 6. The dentalimplant assembly as recited in claim 1, wherein said abutment head isformed by a multiplicity of walls which are integrally connected to saidledge.
 7. The dental implant assembly as recited in claim 6, whereinsaid multiplicity of walls is comprised of a first wall that it issubstantially perpendicular to said ledge.
 8. The dental implantassembly as recited in claim 7, wherein said multiplicity of walls iscomprised of a second wall that is substantially perpendicular to saidledge.
 9. The dental implant assembly as recited in claim 8, whereinsaid multiplicity of walls is comprised of a third wall that forms anacute angle with said ledge.
 10. The dental implant assembly as recitedin claim 9, wherein said acute angle is less than about 75 degrees. 11.The dental implant assembly as recited in claim 6, wherein saidmultiplicity of walls is comprised of a wall that forms an acute anglewith said ledge.
 12. The dental implant assembly as recited in claim 11,wherein said wall that forms an acute angle with said ledge is a linearwall.
 13. The dental implant assembly as recited in claim 12, whereinsaid linear wall is integrally connected an arcuate wall.
 14. The dentalimplant assembly as recited in claim 13, wherein said arcuate wall iscomprised of a multiplicity of splines which have a substantiallyrectangular cross-sectional shape.
 15. The dental implant assembly asrecited in claim 1, wherein said implant body is comprised of abioactive coating.
 16. The dental implant assembly as recited in claim15, wherein said bioactive coating has a thickness of from about 50nanometers to 200 microns.
 17. The dental implant assembly as recited inclaim 16, wherein said bioactive coating has a thickness of from about 1to about 50 microns.
 18. A dental implant assembly comprised of anintegral dental implant, wherein said integral dental implant iscomprised of an abutment head an implant body, and a ledge sectioncomprised of a ledge, wherein said ledge section is disposed between,and integrally joined with, said abutment head and said implant bodywherein: (a) said abutment head is comprised of top section and a bottomsection integrally joined to said top section, wherein: i. said topsection has a shape formed by a linear wall adjacent to an arcuate wall,ii. said abutment head has a length of from about 2 to about 4millimeters (b) said implant body is comprised of a top section and abottom section, wherein said implant body extends upwardly and outwardlyfrom said bottom section to said top section and said implant body hasan irregularly etched surface such that said etched surface has anaverage irregular roughness of from about 10 to about 1,000 microns; and(c) said abutment head is comprised of a first wall that it issubstantially perpendicular to said ledge, forming an angle of fromabout 75 to about 95 therewith, and a second wall that forms an anglewith said ledge, wherein said angle is less than about 75 degrees. 19.The dental implant assembly as recited in claim 18, wherein said firstwall is an arcuate wall.
 20. The dental implant assembly as recited inclaim 19, wherein said second wall is connected to a third arcuate wall,wherein said third arcuate wall is substantially perpendicular to saidledge, forming an angle of from about 75 to about 95 degrees therewith.21. The dental implant assembly as recited in claim 20, wherein anorifice extends through a portion of said top section of said abutmenthead.